Events

Rappel de Device Recall Aaren Scientific Intraocular Lens (IOL), Part No. EC3 PAL

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Aaren Scientific, Incorporated.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    70557
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1309-2015
  • Date de mise en oeuvre de l'événement
    2015-02-13
  • Date de publication de l'événement
    2015-03-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-06-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134031
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    intraocular lens - Product Code HQL
  • Cause
    Aaren scientific is recalling intraocular lenses because the instructions for use (ifu) are not fully compliant with us requirements.
  • Action
    A customer notification letter dated 2/13/15 was sent to all customers who received the Intraocular Lens model EC-3 PAL. The letter provides the customers with the problems identified and the actions to be taken. Customers are instructed to confirm receipt of the recall letter and to contact Mark Scheib at (909) 906-5119 or via email at mark.scheib@zeiss.com with any questions or comments.

Device

Device Recall Aaren Scientific Intraocular Lens (IOL), Part No. EC3 PAL
  • Modèle / numéro de série
    Serial No. 1181331102, 1181321102, 1393231208, 1117161211, 1180941102, 1031031102, 1190261307, 1190231307, 1190091307, 1190101307, 1190431307, 1190441307, 1276591307, 1305951307, 119071307, 1176951102, 1192921102, 1277111307, 1189541307, 1189551307, 1187761307, 1189531307, 1309911307, 1277101307, 1181331102, 1181321102, 1393231208, 1117161211, 1180941102, 1031031102, 1190261307, 1190231307, 1190091307, 1190101307, 1190431307, 1190441307, 1276591307, 1305951307, 1190071307, 1176951102, 1192921102, 1277111307, 1189541307, 1189551307, 1187761307, 1189531307, 1309911307, 1277101307, 1276941307, 1309961307.
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Distributed in the states of OK, KS, FL, and AL.
  • Description du dispositif
    Intraocular Lens (IOL), Part No. EC-3 PAL, Diopter: 17.5, 18.0, 18.5, 19.0, 19.5, 21.5, 23.5, 9.0, 22.5, 23.0, 21.0, 24.0. || The device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. Aaren Scientifics EC-3 IOLs are intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by phacoemulsification.
  • Manufacturer
    Aaren Scientific, Incorporated

Manufacturer

Aaren Scientific, Incorporated
  • Adresse du fabricant
    Aaren Scientific, Incorporated, 4290 E Brickell St Ste A, Ontario CA 91761-1569
  • Société-mère du fabricant (2017)
    Carl-Zeiss-Stiftung
  • Source
    USFDA